The quality of pharmaceutical products is of concern to all individuals, regulators and health care practitioners. This presentation will review the development of standards for pharmaceutical products and their integration into the product development process.

The development of standards for the quality of pharmaceuticals marketed in the United States began on October 3, 1805, when the Massachusetts Medical Society decided that a pharmacopeia was necessary “to secure a uniform mode of compounding medicines.” This evolved into the development of a national pharmacopeia and the publication of the first US Pharmacopeia in 1820. That first pharmacopeia contained a primary list of 221 drugs, a secondary list of 71 drugs and 329 preparations and compositions. The 2004 US Pharmacopeia contains approximately 3200 monographs on the identity, strength and quality of pharmaceutical drugs and dietary supplements.

Standards for the purity of generic products vary significantly. Variables include the type of drug, method of preparation, formulation and the date of revision of the standard. In general, a drug monograph reflects the quality properties of the first proprietary product when it goes off-patent. New information on manufacturing methods or new quality standards necessitates revisions of older monographs.

The methods of drug substance synthesis and product formulation have a significant affect on purity. Drugs prepared via chemical synthesis, generally, have fewer impurities than those prepared from microbial or mammalian cell fermentation. Improvements in chemical analytical techniques have contributed significantly to controlling and reducing the impurities of drug products.

Dr. Northup, a certified toxicologist, has a consulting practice in the safety and toxicology of pharmaceutical and medical products. She is actively involved in developing volunteer and regulatory product standards through the US Pharmacopeia, ASTM (American Society for Testing and Materials), AAMI (Association for the Advancement of Medical Instrumentation), and ISO (International Standards Organization).

Sharon also participated in standards development initiatives of governmental and industrial organizations during her former employment at Baxter Healthcare. She has been as a member of the Committee of Revision of the US Pharmacopeia for 20 years and currently chairs the General Toxicology and Biocompatibility Committee of the USP. She received her Ph.D. in biochemistry from the University of Missouri-Columbia and has numerous publications and memberships in professional organizations.

Updated 12/30/04